FDA WARNING_LETTER - Desert Rose Manufacturing, Inc - July 12, 2012

An FDA inspection of Desert Rose Manufacturing, Inc. (Anthony, NM) on July 10-12, 2012, identified significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) for dietary supplements, rendering products like nuphedrine and alfa PXP Plus adulterated. Deficiencies included failure to establish comprehensive specifications for components, in-process materials, and finished products (21 CFR 111.70), and failure to verify these specifications through adequate testing, including identity and finished product analysis (21 CFR 111.75). Quality control personnel failed to perform required operations (21 CFR 111.105), batch production records were incomplete (21 CFR 111.260), and representative finished product samples were not collected (21 CFR 111.80(c)). The firm also lacked effective measures against foreign material inclusion (21 CFR 111.365(i)), failed to maintain required records (21 CFR 111.605), and lacked essential written procedures (21 CFR Part 111). Sanitation issues were also noted (21 CFR 111.15(h)). Many CGMP violations were repeat observations from prior inspections. Furthermore, several products were misbranded due to non-compliant nutrition labeling, missing supplement facts panels, absent statements of identity, incomplete ingredient declarations, failure to declare net quantity of contents, and inadequate multi-language labeling. The firm's July 30, 2012, response was deemed inadequate due to insufficient documentation and lack of implementation timelines. The FDA requires a detailed response within 15 days outlining corrective actions and supporting documentation to avoid further enforcement, including product seizure or injunction.